AstraZeneca AB v. KV Pharmaceutical Co.

494 F.3d 1011, 83 U.S.P.Q. 2d (BNA) 1545, 2007 U.S. App. LEXIS 17463
CourtCourt of Appeals for the Federal Circuit
DecidedJuly 23, 2007
DocketNo. 2006-1254
StatusPublished
Cited by3 cases

This text of 494 F.3d 1011 (AstraZeneca AB v. KV Pharmaceutical Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
AstraZeneca AB v. KV Pharmaceutical Co., 494 F.3d 1011, 83 U.S.P.Q. 2d (BNA) 1545, 2007 U.S. App. LEXIS 17463 (Fed. Cir. 2007).

Opinions

[1013]*1013Opinion for the court filed by Circuit Judge GAJARSA. Circuit Judge SCHALL dissents in part.

GAJARSA, Circuit Judge.

This is a consolidated multidistrict patent infringement litigation. Plaintiffs As-traZeneca AB, Aktiebolaget Hassle, and AstraZeneca LP (collectively “Astra”) filed multiple suits in various district courts asserting that the Abbreviated New Drug Applications (“ANDA”) filed respectively by Defendants KY Pharmaceutical Co. (“KV”), Andrx Pharmaceuticals, LLC, and Andrx Corp. (collectively “Andrx”), and Eon Labs, Inc. (“Eon”) under 21 U.S.C. § 355© infringe Astra’s patents. Specifically, Astra alleged that Defendants’ ANDAs seeking approval from the Food & Drug Administration to manufacture and market generic versions of Toprol-XL® infringed Astra’s patents pursuant to 35 U.S.C. § 271(e). The Judicial Panel on Multidistrict Litigation consolidated the suits in the District Court for the Eastern District of Missouri. The district court found Astra’s patents invalid and unenforceable, and granted Defendants’ motions for summary judgment. In re Metoprolol Succinate Patent Litigation (“Summary Judgment”), No. 04-1620, slip op., 2006 WL 120343 (E.D.Mo. Jan. 17, 2006).

This court affirms the district court’s invalidity holding based on double patenting. Because a genuine issue of material fact remains, however, we vacate the district court’s inequitable conduct holding and remand the case.

I.

Astra manufactures and markets meto-prolol succinate in “extended release” forms under the brand name Toprol-XL®. Metoprolol is a therapeutically active compound, which can form salts by reaction with acids and is used in the treatment of angina, hypertension, and congestive heart failure. Metoprolol succinate is the salt of metoprolol with succinic acid. See Summary Judgment, slip op. at 2-3.

A. Invention and Ownership

In 1971, an Astra employee “named Toi-vo Nitenberg synthesized metoprolol succi-nate as well as the tartrate and sulfate salts of metoprolol” at Astra’s facilities in Sweden. At the time, Astra chose to commercialize the tartrate salt product. Id. at 28. Similarly in 1982, another Astra employee in Sweden named Lars Lilljequist synthesized a number of metoprolol salts, including metoprolol succinate. The parties submitted conflicting evidence as to whether two other Astra employees in Sweden, Curt Appelgren and Christina Eskilsson, had directed Lilljequist to synthesize metoprolol succinate. See id. at 28-30.

In 1983, Appelgren and Eskilsson left Astra to join another company, Lejus Medical AB (“Lejus”). In January 1984, Lejus filed a patent application (SE 8400085) with the Swedish Patent Office, describing “delayed and extended release dosage forms of pharmaceutical compositions, including metoprolol succinate” and naming Appelgren and Eskilsson as the inventors. In January 1985, Lejus filed U.S. application Ser. No. 690,197 (the '197 Application), claiming priority from the Swedish application. Id. at 30.

In October 1985, after noticing the publication of the Swedish application, Astra commenced a transfer of ownership action with the Swedish Patent Office asserting that Nitenberg, not Appelgren and Eskils-son, invented metoprolol succinate. Astra and Lejus subsequently settled this ownership dispute. Id. at 30-31. In the settlement agreement, Lejus agreed to divide claims to “metoprolol succinate” and to a [1014]*1014“pharmaceutical composition, characterized in that the active substance is meto-prolol succinate” from the '197 Application and to assign the divided claims to Astra. The settlement agreement listed Appel-gren and Eskilsson as the inventors of the divided metoprolol succinate claims. Astra agreed that Lejus retained the rights to the '197 Application that did not include the divided claims.

B.Astra’s U.S. Patents

In March 1988 and in accordance with the settlement agreement, Lejus filed U.S. application Ser. No. 172,897 (the '897 Application), which was a continuation-in-part of the '197 Application. The record indicates that while the settlement agreement resolved the issue of ownership, disagreement remained on the issue of inventor-ship. Lejus filed the '897 Application with Appelgren and Eskilsson as the named inventors. Both before and after the filing, however, Astra’s in-house counsel asserted to Lejus that Nitenberg, not Appel-gren and Eskilsson, was the inventor of metoprolol succinate. Similarly, after Le-jus transferred the prosecution of the '897 Application to Astra, Astra’s in-house counsel asserted to Astra’s outside U.S. patent counsel that “there remains an open question who is the proper inventor.” The last mention of this issue in the record is a phone call between Astra’s in-house counsel and outside U.S. patent counsel in January 1989. Summary Judgment, slip op. at 32-35.

In March 1991, the '897 Application issued as U.S. Patent No. 5,001,161 (the '161 Patent). The only claim of the '161 Patent reads: “A pharmaceutical composition comprising metoprolol succinate together with a sustained release pharmaceutically acceptable carrier.” Id. col.2 11.36-38.

In January 1992, a continuation of the '897 Application issued as U.S. Patent No. 5,081,154 (the '154 Patent). The only claim of the '154 Patent simply reads, “Metoprolol succinate.” Id. col.2 1.36.

The '161 and '154 Patents both list Ap-pelgren and Eskilsson as the inventors, and Astra as the assignee. Astra never revealed the inventorship issue to the U.S. Patent & Trademark Office during the prosecution of the two patents. Summary Judgment, slip op. at 25.

C. Lejus’s U.S. Patent

During the same time period, Lejus’s '197 Application issued as U.S. Patent No. 4,780,318 (the '318 Patent) in October 1988. Lejus is the assignee of the '318 Patent, which also lists Appelgren and Eskilsson as the inventors. While Lejus, Appelgren, and Eskilsson are not parties in this multidistrict litigation, the '318 Patent is pertinent because the district court invalidated Astra’s '161 and '154 Patents as double patenting over Lejus’s '318 Patent. Claim 6 of the '318 Patent claims an improved release oral pharmaceutical composition having (i) “a core comprising the therapeutically active compound,” (ii) “a first inner layer coating on the core,” and (in) “a second outer layer coating on the inner layer.” Id. col.5 11.42-55. Claim 8 claims this composition,

wherein the active compound is quini-dine sulphate, quinidine bisulphate, qui-nidine gluconate, quinidine hydrochloride, metoprolol tartrate, metoprolol succinate, metoprolol fumarate, or fu-rosemide, 5-aminosalicylie aicd [sic], propranolol or alprenolol or a pharma-ceutically acceptable salt thereof, or a mixture thereof with another weak base, weak acid, or salt thereof having a pka of 1 to 8.

Id. col.5 11.61-68 (emphasis added).

D. Procedural History

Defendants KV, Andrx, and Eon each filed an ANDA under 21 U.S.C. § 355(j) [1015]

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494 F.3d 1011, 83 U.S.P.Q. 2d (BNA) 1545, 2007 U.S. App. LEXIS 17463, Counsel Stack Legal Research, https://law.counselstack.com/opinion/astrazeneca-ab-v-kv-pharmaceutical-co-cafc-2007.